Randomised, double-blind, placebo-controlled, monocentric phase III study on the efficacy and safety of Lidocaine 8 mg Sore Throat Lozenges in patients with moderate to severe acute sore throat not necessarily to be treated with antibiotics - Lidocaine 8 mg sore throat lozenges vs. placebo

• Conditions: The study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibiotics

• Registration Number: EUCTR2004-005095-17-DE
• Lead Sponsor: Engelhard Arzneimittel GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-05
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients of both genders will be enrolled. They must fulfil all the following criteria before being enrolled in the study:
- Age: > 18 years.
- Patients with moderate to severe throat pain (³60 mm VAS) due to acute
pharyngitis of recent onset (within preceding 48 hours) not requiring antibiotic
treatment.
- The patient must give written informed consent, after having been informed about
benefits and potential risks of the trial, as well details of the insurance taken out to
cover the subjects participating in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are to be excluded from the study if they display any of the following criteria:
- Hypersensitivity to lidocaine hydrochloride, local anaesthetics of the amide type or
any of the excipients of the study drugs.
- Known or suspected primary or secondary bacterial pharyngitis or
tonsillopharyngitis (e.g. clinical finding of purulent, serous or fibrinous exudate from
the pharyngeal mucosa).
- Known or suspected oro-pharyngeal mycosis.
- Presence of severely traumatised and / or very severe inflammation of the oro
-pharyngeal mucosa.
- Severe lower respiratory tract infection (pneumonia, bronchitis) requiring antibiotic
treatment.
- Acute rhino-sinusitis or laryngitis requiring antibiotic treatment.
- Fever (>38°C oral).
- Systemic treatment with analgesics (within the last 12 hours) or non-steroidal anti
-inflammatory drugs, COX-2 inhibitors (within the last 24 hours) prior to enrolment
except long-term treatment with low-dose ASA (£ 100 mg ASA per day).
- Treatment with codeine containing cough preparations within the last 12 hours
prior to enrolment.
- Topical oro- or nasopharyngeal use of local anaesthetics and / or antiseptic
formulations (such as lozenges, pharyngeal washes, breath spray, inhalation) or
use of herbal teas used for the treatment of common cold within the last 6 hours
prior to enrolment.
- Concomitant systemic propranolol treatment.
- Concomitant systemic cimetidine treatment unless the treatment will be interrupted
the latest 6 hours prior to first intended lidocaine treatment.
- Systemic or topical (oro-pharyngeal) treatment with an antibiotic agent within the
last week prior to enrolment.
- Known fructose intolerance.
- Known medical condition associated with chronic pain, clinically relevant acute
disease (at the investigator’s judgement), known current haematopoietic or
malignant disorder.
- Presence of relevant neurological or psychiatric disorder or mental impairment.
- Pregnancy or breast feeding.
- Women of childbearing potential unable or unwilling to practice adequate
contraceptive measures.
- Heavy smoker (³ 20 cigarettes per day).
- Suspicion of alcohol abuse, drug addiction or any other condition of the patient that
at the investigator’s discretion may jeopardise patient’s compliance or adherence
to protocol requirements.
- Previous participation in this study or participation in any other drug investigational
trial within the preceding 30 days.
- Volunteers suspected or known not to follow the instructions.
The exclusion criteria are chosen to assure that patients with specific risks for administration of the investigated drug and patients with conditions which may have an impact on efficacy parameters are excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified